PMA P200004

Device
ConMed PadPro Multifunction Electrodes
Applicant
Conmed Corporation
PMA number
P200004
Supplement
S001
Product code
MKJ
Decision date
2022-06-16
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Change the test site for sterilization test samples and remove redundant post-sterile finished device testing.

Current openFDA PMA Record#

Device
ConMed PadPro Multifunction Electrodes
Applicant
Conmed Corporation
PMA number
P200004
Supplement
S001
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2022-06-16
Decision code
OK30
Date received
2022-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change the test site for sterilization test samples and remove redundant post-sterile finished device testing.